New stomach cancer surgery technique shows promise in early trial
NCT ID NCT05545293
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a new way to reconnect the stomach and small intestine after removing the lower part of the stomach in people with advanced stomach cancer. The goal was to see if the new stapling method was safe and worked well. One hundred patients took part, and the researchers tracked complications, recovery time, and quality of life after surgery.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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100 people
The number who actually took part.
- Started
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Sep 2017
- Finished
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Dec 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
All eligible patients enrolled in this study would undergo double-stapling end-to-end gastroduodenostomy Billroth-I anastomosis in laparoscopy-assisted surgery
- Ages
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18 to 85 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age from 18 to years (including 18 and 85years old) * Pathological diagnosis of primary focus is gastric adenocarcinoma made by endoscopic biopsy (papillary, tubular, mucinous, signet ring cell, poorly differentiated) * cT1-4a, N+/-, M0 at preoperative evaluation * No peritoneal metastasis or other distant metastases of gastric carcinoma (affirmed by laparoscopic surgery and related imaging examinations) * Expected curative resection through laparoscopic distal gastrectomy with D2 lymphadenectomy (include multiple primary lower gastric adenocarcinoma) * Performance status of 0 or 1 on Eastern Cooperative Oncology Group scale (ECOG) * Preoperative American Society of Anesthesiology score (ASA) classⅠ, Ⅱ or Ⅲ * Major organs are functioning normally: blood routine test (No blood transfusions in the last 14 days): HB≥90g/L, ANC≥1.5×109/L, PLT≥80×109/L blood biochemical examination: BIL\<1.5× upper limit of normal (ULN), ALT and AST\<2.5×ULN, Crea≤1×ULN. \- The subject is willing to participate in this clinical trail Exclusion Criteria: * History of previous upper abdominal surgery (include ESD/EMR, except laparoscopic cholecystectomy) * History of acute pancreatitis * Regional fusion of enlarged lymph nodes by preoperative imaging (maximum diameter \>3cm) * History of other malignant disease within past five years * History of unstable angina, myocardial infarction, cerebral infraction, or cerebral hemorrhage within past six months * History of continuous systematic corticosteroids therapy within past one month * Requirement of simultaneous surgery for other disease * Emergency surgery due to complication (bleeding, or perforation) caused by gastric cancer * FEV1\<50% of predicted values by pulmonary function test * Women during pregnancy or breast-feeding * Severe mental disorder * Participating in other clinical studies simultaneously * Refusing to sign the informed consent for the study * Peritoneal implant or other distant metastases by intraoperative exploration * Unresectable due to tumor reasons by intraoperative exploration * Distal gastric cancer surgery cannot be performed after intraoperative exploration * Duodenal bulb has been invaded by tumor or gastroduodenostomy cannot be performed due to additional surgical resection cause by positive intraoperative frozen margin
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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West China Hospital, Sichuan University
Chengdu, Sichuan, 610041, China
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Other studies related to the condition(s) this trial covers.
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